Covariate Adjustment in Chronic Pain Trials: An Oft-Missed Opportunity.

ABSTRACT: Self-reported pain intensity, frequently used as an outcome in randomized clinical trials (RCTs) of chronic pain, is often highly variable and could be associated with multiple baseline factors. Thus, the assay sensitivity of pain trials (ie, the ability of the trial to detect a true treatment effect) could be improved by including prespecified baseline factors in the primary statistical model. The objective of this focus article was to characterize the baseline factors included in statistical analyses of chronic pain RCTs. Seventy-three RCTs published between 2016 and 2021 that investigated interventions for chronic pain were included. The majority of trials identified a single primary analysis (72.6%; n = 53). Of these, 60.4% (n = 32) included one or more covariates in the primary statis

SUBMITTER: Langford DJ 

PROVIDER: S-EPMC11261744 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature